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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020627
Receipt No. R000023770
Scientific Title Efficacy Study of COmbination of Edoxaban and Physiotherapy on PRevention and Thrombogenicity of Venous-Thromboembolism in patients after Total Knee Arthroplasty
Date of disclosure of the study information 2016/01/20
Last modified on 2018/02/12

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Basic information
Public title Efficacy Study of COmbination of Edoxaban and Physiotherapy on PRevention and Thrombogenicity of Venous-Thromboembolism in patients after Total Knee Arthroplasty
Acronym Efficacy Study of COmbination of Edoxaban and Physiotherapy on PRevention and Thrombogenicity of Venous-Thromboembolism in patients after Total Knee Arthroplasty(ESCORT-TKA Study)
Scientific Title Efficacy Study of COmbination of Edoxaban and Physiotherapy on PRevention and Thrombogenicity of Venous-Thromboembolism in patients after Total Knee Arthroplasty
Scientific Title:Acronym Efficacy Study of COmbination of Edoxaban and Physiotherapy on PRevention and Thrombogenicity of Venous-Thromboembolism in patients after Total Knee Arthroplasty(ESCORT-TKA Study)
Region
Japan

Condition
Condition knee arthrosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Deep vein thrombosis often occur fatal pulmonary thromboembolism. Edoxaban is an activated factor ten inhibitor, which has proven the prevention of thromboembolic events in venous thromboembolism(VTE). Recently, the Total Thrombus-formation Analysis System(T-TAS), a microchip-based flow chamber system capable of evaluating thrombogenicity was developed. In this study, we will examine in the incidence of VTE after knee surgery and evaluate how thrombosis forms by utilizing T-TAS.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Differences in incidence rate of venous thromboembolism 7 days after opetration,and the changes in T-TAS parameters between edoxaban plus physiotherapy group and physiotherapy only group.


Key secondary outcomes Between edoxaban plus physiotherapy group and physiotherapy only group,differences in incidence rate of perioperative bleeding event and the changes in PT and aPTT
function.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 edoxaban plus physiotherapy group

Oral administration of 30 mg of edoxaban once daily will be initiated from the second day after the TKA.
Interventions/Control_2 physiotherapy only group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1)Meet the diagnostic criteria for TKA
2)Aged from 16 to 85 years old
3)Willingness to give written informed consent and willingness to participate in and comply with the study
Key exclusion criteria 1)Emergent operation
2)Serious infection
3)Allergy to study drug
4)Current thrombosis
5)Taking anti-thrombotic agents such as, aspirin, P2Y12 inhibitor, warfarin and non-vitamin K oral anticoagulants (NOACs), etc.
6)Unwilling to give informed consent
7)inappropriate patient
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Tsujita
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1, Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
TEL +81-96-373-5175
Email tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Sueta
Organization Kumamoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1, Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
TEL +81-96-373-5175
Homepage URL
Email sueta-d@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University Hospital, Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization This study was supported in part by Grants-in-Aid for Scientific Research (#15K09089) from the Ministry of Education, Culture, Sports, Science and Technology of Japan.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Janan

Other related organizations
Co-sponsor Kumamoto University Hospital, Department of Orthopedic Surgery
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 熊本大学医学部附属病院(熊本県) (Kumamoto University Hospital,Kumamoto Pref.)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 19 Day
Last modified on
2018 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023770

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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